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R&D Engineer
Galway
Buyer
Cork
QA Manager
Dublin North
Snr QA Specialist
Dublin South
Senior CRA
Dublin
Snr QA Officer
Dublin North
Program Manager
Westmeath
Product Specialist (Microbiology)
Republic of Ireland
Biostatistician
Dublin City Centre
Head of Quality
Dublin West
QA Manager Biologics
Dublin West
QA Manager
Meath
QA Manager
Dublin West
R&D Engineer
Dublin
API Purchaser
Dublin
Consultant
Brian Christensen
Life Science

+353 (0)1 685 47 47
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Search Results for Regulatory Affairs Officer
Job Title. Location Salary Actions

Regulatory Affairs & Labelling Specialist

Regulatory Affairs & Labelling Specialist Our client, a Irish owned organisation are currently recruiting for a Regulatory Affairs and Labelling Specialist to join their team. This is a permanent opportunity and the successful candidate will report directly into the Head of Quality and Regulatory Affairs. Responsibilities ·Execute and complete tasks and deliverables for CE marking activities as required to IVD directive ·Provide update and maintain status of product registration and notifications ·Provide documentation and certifications upo...

Location: Tipperary,
Regulatory Affairs & Labelling Specialist
Tipperary Not Disclosed

Regulatory Affairs Manager

Regulatory Affairs Manager Our client requires a Regulatory Affairs Manager to joint their team. The ideal candidate will have excellent experience in the are

Location: Kerry,
Regulatory Affairs Manager
Kerry Not Disclosed

Regulatory Affairs Manager

Regulatory Affairs Manager Our client is an international pharmaceutical discovery organisation and they are currently recruiting for a Regulatory Affairs Manager to join their team on a permanent basis. The ideal candidate will be a dynamic individual, who is self-driven, organized and capable of working on their own initiative in a start-up environment. Responsibilities • Coordinate, prepare and be accountable for all regulatory affairs related activities such as clinical trial applications, organization and preparation of regulatory advice meetings and compilation...

Location: Dublin,
Regulatory Affairs Manager
Dublin Not Disclosed

Senior Regulatory Compliance Officer

Senior Regulatory Compliance Officer Our client, a global healthcare organisation, requires a Senior Regulatory Compliance Officer to join their team for fixed term contract, the duration of which is 6 months. The successful candidate will manage, review registration information and provide this information to relevant departments, and to ensure regulatory compliance for all products released. Responsibilities • Manage the review of registration information supplied by various regional registration centres and provide the information as appropriate to the relevant...

Location: Dublin,
Senior Regulatory Compliance Officer
Dublin Not Disclosed
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Senior Regulatory Affairs Specialist Westmeath Not Disclosed
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Senior Director, Regulatory Affairs Dublin Not Disclosed
Veterinary Assessment Manager Dublin Not Disclosed
Senior Director, Regulatory Affairs Dublin Not Disclosed
Regulatory Affairs Specialist Galway Not Disclosed
Research and Development Compliance Specialist Galway Not Disclosed
CMC Regulatory Affairs Director Dublin Not Disclosed
Senior Regulatory Affairs Specialist Westmeath Not Disclosed

Regulatory Affairs Officer Career Profile

Regulatory Affairs Officer


The Regulatory Affairs (RA) department is tasked with ensuring that the company complies with all of the local and international regulations and laws pertaining to their business. The Regulatory Affairs Officer works with international, state and local regulatory agencies, such as the Irish Medicines Board (IMB), the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) on specific issues affecting their business. The Regulatory Affairs Officer advises the company on the current regulatory aspects and climate that would affect proposed activities. The RA Officer has many interactions within the medical affairs dept. including medical information, pharmacovigilance and clinical trials.

Key responsibilities of the Regulatory Affairs Officer


  • Maintenance of Irish and overseas licenses including preparation of variation and renewal applications as appropriate.
  • Preparation and submission of Marketing Authorisation applications to EU regulatory authorities.
  • Preparation of dossiers to obtain CE marking for medical devices.
  • Ensuring Labelling complies with appropriate legislation.
  • Ensure approved regulatory requirements are enforced in-house.
  • Participate in the development of electronic submission of dossiers.
  • Provide support to R&D projects; including new product introductions, changes to existing products and processes.
  • Liaise with suppliers, clients, development partners and regulatory bodies.
  • Ensure guidelines and knowledge of legislation is current and be able to advise of future developments and changes.
  • Monitor the process of regulatory submissions, responding to queries and ensuring that registration approvals are granted without undue delay.